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NCT Number: NCT05096338

Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer

This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Heart Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Radiation Injuries Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

The investigators propose a prospective longitudinal cohort of prostate cancer patients treated with Androgen Deprivation Therapy (ADT) to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine wither associations between SDOH and cardiotoxicity risk differs according to race. Patients will be followed with serial echo, blood draw, and surveys prior to start of ADT and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of ADT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men older than 18 years of age Prostate cancer diagnosis planned for treatment with ≥6 months of ADT (with or without RT) for clinically localized, biochemically recurrent, or oligometastatic disease. Planned ADT regimens may include: GnRH agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and GnRH antagonists (degarelix). Additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with GnRH agonist/antagonist therapies per provider clinical discretion.

Ability to provide informed consent

Exclusion criteria

Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent

Treatment and study plan

Social Determinants of Health

Other

We will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Time frame: through study completion (expected to be 15 years)

    Absolute change in LVEF by echocardiogram at follow-up

Secondary outcomes

  1. Cancer therapy-related cardiac dysfunction (CTRCD)

    Time frame: through study completion (expected to be 15 years)

    Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value < 50%

  2. Symptomatic Heart Failure (HF)

    Time frame: through study completion (expected to be 15 years)

    Incidence of symptomatic heart failure (centrally adjudicated)

  3. Change in Longitudinal Strain

    Time frame: through study completion (expected to be 15 years)

    Change in longitudinal strain by echo from baseline

  4. Change in Circumferential Strain

    Time frame: through study completion (expected to be 15 years)

    Change in circumferential strain by echo from baseline

  5. Change in Diastolic function

    Time frame: through study completion (expected to be 15 years)

    Change in diastolic function defined as E/e' by echo from baseline

  6. Change in Left Ventricular (LV) Mass

    Time frame: through study completion (expected to be 15 years)

    Change in LV Mass by echo from baseline

  7. Change in Relative LV Wall Thickness

    Time frame: through study completion (expected to be 15 years)

    Change in relative LV wall thickness from baseline

  8. Change in Ventricular-Arterial Coupling

    Time frame: through study completion (expected to be 15 years)

    Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline

  9. Change in LV Twist

    Time frame: through study completion (expected to be 15 years)

    Change in LV Twist measured by 3D echo from baseline

  10. Change in LV Torsion

    Time frame: through study completion (expected to be 15 years)

    Change in LV Torsion measured by 3D echo from baseline

  11. Change in NTproBNP

    Time frame: through study completion (expected to be 15 years)

    Change in NTproBNP measured in batches from banked samples from baseline.

  12. Change in high-sensitivity troponin (hsTnT)

    Time frame: through study completion (expected to be 15 years)

    Change in hs-TnT measured in batches from banked samples from baseline.

  13. Change in patient reported fatigue

    Time frame: through study completion (expected to be 15 years)

    Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue.

  14. Change in patient reported quality of life

    Time frame: through study completion (expected to be 15 years)

    Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient.

  15. Change in patient reported activity level

    Time frame: through study completion (expected to be 15 years)

    Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy

Acronym: PCT

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Oct 27, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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